Major Depressive Disorder (MDD)
Conditions
Keywords
Depression, Major Depressive Disorder, Major Depression, MDD
Brief summary
The purpose of this randomized, double-blind, placebo-controlled study is to assess the safety and efficacy of PRX-00023 in patients with major depressive disorder.
Detailed description
Patients with major depressive disorder who meet all of the eligibility criteria will be randomly assigned to receive twice daily doses of either placebo or PRX-00023. Study drug will be taken for up to approximately 9 weeks. Patients will have periodic office visits for the purpose of monitoring safety and tolerability, as well as efficacy assessments.
Interventions
DRUGPRX-00023
Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
DRUGPlacebo for PRX-00023
Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
Sponsors
Epix Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of major depressive disorder Key
Exclusion criteria
* Females who are pregnant or nursing * Electroconvulsive therapy within previous year * Type 1 diabetes or uncontrolled type 2 diabetes * HIV, Hepatitis B or Hepatitis C * Use of illegal drugs, history of drug abuse, and/or alcohol dependence * Clinically significant abnormal lab results Other protocol-defined eligibility criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS). | change from baseline through end of study |
Secondary
| Measure | Time frame |
|---|---|
| changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale | change from baseline through end of study |
| changes from baseline on the Quick Inventory of Depressive Symptomatology-self report (QIDS-SR) | change from baseline through end of study |
| Side effects during and immediately following the treatment period | assessed throughout study |
| responder and remission rates | change from baseline through end of study |
| changes from baseline on the Changes in Sexual Function (CSFQ) scale. | change from baseline through end of study |
| changes from baseline on the Clinical Global Impressions (CGI) scale | change from baseline through end of study |
Countries
United States
Outcome results
None listed